Molecular Diagnostics

Abbott Labs developing molecular technology for broad, rapid pathogen detection

New tech set to accelerate accurate diagnosis

Middle East Health spoke to Deepak Nath, DVP of Abbot Labs. He discusses a new molecular diagnostic tool that US-based Abbot Labs is currently developing and which promises to bring new hope to patients with critical infections.

Patients with critical infections face a high risk of mortality because they are poorly served by existing diagnostic tools says Deepak Nath, DVP of Abbot Labs, explains that patients admitted to hospital with unknown infection or are already in hospital and acquire infection have to rely on current diagnostic methods which are at best slow to provide results. These methods entail extracting a blood sample which is sent to the lab where it is cultured. The hope is to detect the pathogens that are causing the infection. The issue with this is the time it takes, which can be days or even weeks, in the case of fungal infections, before a reliable diagnosis can be made.

“So what physicians do today is they have to guess,” says Nath. “They start patients on a broad antimicrobial treatment while they wait for the lab results. There is a problem with this. Firstly, it deals with guesswork – they have to prescribe a relatively broad spectrum antibiotic, sometimes, because they have to guess, they end up giving the wrong type of antimicrobial treatment.”

The second issue, he points out, is the fact that you are putting someone on a treatment tends to influence the culture results and throw up a lot of false negatives in the results.

“These patients are very, very sick. They are patients with bloodstream infections, like sepsis; or pneumonia; or immuno-compromised patients who have undergone organ transplant procedures,” Nath says.

Every year about 8 million people around the world are diagnosed with sepsis. About 6 million are hospitalised for pneumonia and about 160,000 immuno-compromised patients are hospitalised with infections. The single leading cause of death for transplant patients is infection.

Many of these deaths can be prevented – if the right diagnostic information is available.

What Abbot Labs is developing is a new DNA-based technology (more commonly known as molecular diagnostics). This technology promises to deliver results within six hours. Abbot Labs’ particular diagnostic tool is not yet named as it is still in development.

“We are testing it for 600 pathogens, bacteria and different viral families,” Nath says.

“By providing accurate results in such a short time it will enable physicians to confidently rule out certain infections and provide them the information they need to make an accurate diagnosis.”

The technology in development has the ability to extract the pathogen DNA from the sample (blood or other body fluids) and test it for a broad range of pathogens.

“The combination of quick turnaround and accuracy translates into significant costsavings for healthcare systems,” Nath points out, “because by identifying the pathogen early you are able to initiate the appropriate treatment quicker, which translates into a shorter hospital stay overall.”

Asked what time scale they are looking at for commercialisation, Nath says: “We are looking at bringing this to market within the next 12-14 months [the first quarter of 2015] when we expect to launch the product in Europe and Middle East. The US launch will come later as FDA certification requires significantly more trial data.

“We expect to initiate trials for certification later this year.”

He noted that the technology is well studied with more than 100 publications about it in peer-reviewed journals.

“Molecular diagnostics is a very rich area. There are many companies participating in this field, however there is no company that we are aware of that has developed the technology to cover such a broad scope of pathogens and provide results as quickly as we can from sample acquisition to result without the need for culture. This is the key differentiator for us.”

In conclusion Nath emphasises a crucial point: “This technology has the potential to positively impact a large number of patients and possibly save many lives in the process.”

Date of upload: 16th May 2014

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